Department of Paediatrics, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia.
Department of Pediatric Endocrinology, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates.
Pediatr Diabetes. 2022 Mar;23(2):183-193. doi: 10.1111/pedi.13282. Epub 2021 Dec 20.
To assess the efficacy and safety of sitagliptin in youth with type 2 diabetes (T2D) inadequately controlled with metformin ± insulin.
Data were pooled from two 54-week, double-blind, randomized, placebo-controlled studies of sitagliptin 100 mg daily or placebo added onto treatment of 10- to 17-year-old youth with T2D and inadequate glycemic control on metformin ± insulin. Participants (N = 220 randomized and treated) had HbA1c 6.5%-10% (7.0%-10% if on insulin), were overweight/obese at screening or diagnosis and negative for pancreatic autoantibodies. The primary endpoint was change from baseline in HbA1c at Week 20.
Treatment groups were well balanced at baseline (mean HbA1c = 8.0%, BMI = 30.9 kg/m , age = 14.4 years [44.5% <15], 65.9% female). The dose of background metformin was >1500 mg/day for 71.8% of participants; 15.0% of participants were on insulin therapy. At Week 20, LS mean changes from baseline (95% CI) in HbA1c for sitagliptin/metformin and placebo/metformin were -0.58% (-0.94, -0.22) and -0.09% (-0.43, 0.26), respectively; difference = -0.49% (-0.90, -0.09), p = 0.018; at Week 54 the LS mean (95% CI) changes were 0.35% (-0.48, 1.19) and 0.73% (-0.08, 1.54), respectively. No meaningful differences between the adverse event profiles of the treatment groups emerged through Week 54.
These results do not suggest that addition of sitagliptin to metformin provides durable improvement in glycemic control in youth with T2D. In this study, sitagliptin was generally well tolerated with a safety profile similar to that reported in adults. (ClinicalTrials.gov: NCT01472367, NCT01760447; EudraCT: 2011-002529-23/2014-003583-20, 2012-004035-23).
评估西他列汀在二甲双胍±胰岛素治疗控制不佳的青少年 2 型糖尿病（T2D）患者中的疗效和安全性。
本研究对两项 54 周、双盲、随机、安慰剂对照的研究数据进行了汇总，这些研究纳入了 10-17 岁 T2D 青少年患者，他们在接受二甲双胍±胰岛素治疗时血糖控制不佳，且糖化血红蛋白（HbA1c）为 6.5%-10%（如果正在使用胰岛素，则为 7.0%-10%），且超重/肥胖，在筛查或诊断时存在胰腺自身抗体阴性。主要终点是第 20 周时与基线相比 HbA1c 的变化。
两组患者基线时具有良好的均衡性（平均 HbA1c 为 8.0%，体重指数 [BMI] 为 30.9kg/m²，年龄为 14.4 岁[44.5%<15]，65.9%为女性）。71.8%的参与者使用的背景二甲双胍剂量>1500mg/天；15.0%的参与者接受胰岛素治疗。第 20 周时，西他列汀/二甲双胍和安慰剂/二甲双胍的 LS 均值（95%CI）HbA1c 变化分别为-0.58%（-0.94，-0.22）和-0.09%（-0.43，0.26）；差值为-0.49%（-0.90，-0.09），p=0.018；第 54 周时，LS 均值（95%CI）变化分别为 0.35%（-0.48，1.19）和 0.73%（-0.08，1.54）。在第 54 周时，两组不良事件的发生情况没有明显差异。
这些结果表明，西他列汀不能为 T2D 青少年提供持久的血糖控制改善。在这项研究中，西他列汀总体耐受性良好，安全性与成人报告的相似。（临床试验.gov：NCT01472367，NCT01760447；EudraCT：2011-002529-23/2014-003583-20，2012-004035-23）。
